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Месечни архиви: August 2017

In January 2017, the Commission tabled a proposal for a regulation on privacy and electronic communications which would replace the current 2002 e-Privacy Directive. The main objectives of the review are: enhancing security and communications confidentiality; defining clearer rules on tracking technologies such as cookies; and achieving greater harmonisation among Member States.

Stakeholders are divided on certain issues, including on the basic need for a new measure to protect confidentiality in e-communications. Some national parliaments have made comments on the proposal, and discussions are progressing in Council. In the European Parliament, rapporteur Marju Lauristin (S&D, Estonia) presented a draft report to the Civil Liberties Committee on 21 June 2017, and this is expected to be voted in October 2017.

Smoking is the largest preventable cause of death in Europe. In the past decade, EU laws on tobacco additives, advertising and packaging have reinforced efforts to deter people, especially the young, from taking up smoking. The ‘Ex-Smokers are Unstoppable’ campaign has helped many kick the habit. Today, taking their lead from the 2004 Irish ban on smoking in workplaces, diverse actions protect Europeans from breathing in harmful ‘second-hand’ smoke (or ‘passive smoking’) in public venues.

Health risks of active and passive smoking

Eurostat data (2014) show that in the EU, one in every four persons aged 15 or over is a smoker, and that one in five is exposed to ‘second-hand’ smoke coming from lit cigarettes or being exhaled by smokers. Smoking is responsible for about 90 % of lung cancers. It also causes other forms of cancer, including of the mouth, lips, throat, larynx, oesophagus, bladder, kidney, liver and pancreas. It damages the heart and blood circulation, raising the risk of cardiovascular diseases, and can lead to lung conditions, such as chronic obstructive pulmonary disease (COPD) and pneumonia. Passive smoking increases non-smokers’ risk of developing the same health problems as smokers. Babies and children are particularly vulnerable to its effects. According to the World Health Organization (WHO), there is no safe level of exposure to second-hand smoke, and it has been classified as ‘carcinogenic to humans’. Non-smokers breathing in second-hand smoke in the workplace are at a 16-19 % increased risk of developing lung cancer. The risk of acute coronary syndrome is 25-35 % higher among passive smokers, and they also suffer from chronic respiratory diseases, such as asthma, more frequently.

EU action to promote smoke-free environments

The EU’s tobacco policy is mainly aimed at protecting people from the harmful effects of active and passive smoking. The measures range from legislation to awareness-raising, and include, among other things:

anti-tobacco campaigns, such as ‘Ex-Smokers are Unstoppable’ (2011-2016). It targeted EU smokers aged 25-34 years (almost 28 million people), with over 480 000 benefitting from the iCoach tool;

limitations on venues where smoking is allowed. These go back to the 2009 Council recommendation on smoke-free environments, which called on Member States to protect their citizens from exposure to tobacco smoke in indoor workplaces, indoor public places, public transport and other public places. Legislation on smoke-free environments is the Member States’ responsibility, so the EU’s role is mainly one of fostering cooperation. A 2013 report on how the recommendation was implemented found that all Member States had adopted measures, albeit to varying extents, but that enforcement was an issue. The report nevertheless showed that actual exposure rates for EU citizens had dropped, and that the positive health effects of smoke-free legislation had been immediate.

A 2014 Eurobarometer survey illustrated that exposure to second-hand tobacco smoke continued to decline. In the past six months, only 12 % of respondents had been exposed to smoke in restaurants, and 25 % in bars. Some 73 % of workers in Europe had rarely or never been exposed to smoke indoors in their workplace.

This note has been prepared by EPRS for the European Parliament’s Open Days in May 2017.

Our natural environment has improved measurably since the European Community first took up its environmental policy in the early 1970s. These improvements are a result of the comprehensive EU environmental legislation, which is applicable in all Member States alike. EU environmental policy is committed to protecting natural resources essential to human health and well-being, as well as to safeguarding nature with its wide range of benefits.

Healthy natural resources

Every living being depends on safe water for its survival. On average, each European uses 100-200 litres of tap water a day. To ensure that water can be consumed safely everywhere in the EU, the Drinking Water Directive has set a number of quality standards providing limit values for substances or micro-organisms that could endanger human health. Over 98.5 %[1] of EU drinking water meets these standards. Bathing water in lakes and seas is potentially exposed to risks, for instance, of pollution by bacteria, and is therefore subject to quality standards set by the Bathing Water Directive. In 2015, 96 % of bathing water sites across Europe met the minimum requirements, and more than 84 % were classified as having excellent water quality. In addition to the international Blue Flag for beaches, specific signs indicate the quality of bathing water across the EU.

Rivers and lakes in European urban areas used to be under particular pressure due to pollution and flow alteration, but are currently coming back to life. For instance, many fish species have returned to the River Rhine, just as they have to the rivers in Paris, London, Dublin and Stockholm. In some cities, such as Copenhagen and Munich, it is now possible once again to bathe in the waters close to the city centre.

Thanks to European water protection legislation, freshwater bodies today are much cleaner than they were 25 years ago. The Water Framework Directive – the centrepiece of EU water protection policy – requires EU Member States to achieve a good status for all surface water and groundwater bodies, allowing only a slight deviation from natural, undisturbed conditions. To reach this goal, Member States must keep on tackling issues such as pollution and over-abstraction.

Protected areas for the good of nature and people

Many areas within the EU belong to a nature protection network, known as Natura 2000. It covers about 18 % of the EU’s land area and 6 % of EU seas and is the largest coordinated nature protection network in the world. With its aim being to safeguard Europe’s most valuable and threatened species as well as their habitats, the network is crucial to EU nature protection policy. In 2016, the European Parliament expressed concern about the ongoing loss of wild species, and urged the European Commission and the Member States to give higher priority to nature protection. Safeguarding EU nature is not only an end in itself. Communities of plants, animals and micro-organisms, alongside their non-living environment, provide services, such as production of food and medicines, pollination, climate regulation, flood protection and soil fertility, which are of vital importance to humans and society.

Greater energy efficiency can help to reduce the bills that consumers pay for their heating and electricity, and contributes to the fight against climate change because lower energy consumption leads to fewer greenhouse gas emissions. Energy efficiency can also foster greater energy security in the EU, by reducing the need for energy imports (mainly fossil fuels) from outside the bloc.

EU framework for energy efficiency

The EU and its Member States have committed to an improvement of at least 20 % in energy efficiency by 2020. The Energy Efficiency Directive (2012) sets an overall limit on EU energy consumption by 2020 (1 086 million tonnes of oil equivalent (Mtoe) in final energy; 1 483 Mtoe in primary energy) as well as national targets. The European Commission’s second report on the state of the energy union (2017) suggests the EU is on track to meet its goal – in 2014 final energy consumption was already 2.2 % below the 2020 limit. The Commission has proposed a binding 30 % improvement in energy efficiency by 2030. The Parliament has called for a more ambitious but still binding target of 40 % improvement by 2030.

Ecodesign and energy labelling

One of the ways in which the EU seeks to improve energy efficiency is by encouraging the manufacture and purchase of ever more efficient household appliances. Stringent ecodesign requirements ensure only the most efficient appliances are sold on the EU market, while compulsory energy labelling helps to inform consumers about the energy consumption of individual products. The Commission has prepared a 2016-2019 ecodesign work-plan, including a list of new product groups to be covered by EU legislation. In 2015 the Commission issued a legislative proposal to revise the framework for energy labelling, in order to improve consumer awareness and market monitoring of real energy consumption. On 21 March 2017, agreement was reached between the Council and the Parliament on this regulation, which should be adopted in the coming months.

Energy performance of buildings

There is great potential for buildings in the EU to become more energy efficient. This would reduce energy consumption and combat energy poverty, a social problem exacerbated by inefficient housing stock. Buildings absorb 40 % of final energy consumption in the EU, however 75 % of the existing building stock is energy inefficient and less than 1 % is renovated each year. The Energy Performance of Buildings Directive (2010) obliges Member States to ensure that from 2021, all new or heavily renovated buildings are nearly Zero Energy Buildings (nZEB). As part of its clean energy package, the Commission proposed several improvements to the Buildings Directive and has introduced a ‘smart finance for smart buildings initiative’, in order to better concentrate EU funding on building renovations that can improve energy efficiency and/or allow self-generation and consumption of renewable energy sources, making use of the latest technologies.

Competitive markets and smart metering

The EU single market in energy is designed to foster competition and ensure that national energy markets are better interconnected. The European Council has set minimum electricity interconnection targets for EU Member States (10 % by 2020, 15 % by 2030). The empowerment of consumers is crucial for a well-functioning market, and with this in mind EU legislation has enshrined several rights for energy consumers. Energy efficiency can be improved by smoothing out supply and demand over time, the reduction in ‘demand peaks’ also helps to lower the operating costs for the energy grid and the financial burden on consumers. Yet to be empowered, consumers must be aware of their consumption levels and benefit financially from adjusting their energy use to variable pricing (‘demand response’). EU legislation encourages Member States to deploy widely gas and electricity smart meters that provide accurate and (almost) real-time data on energy consumption.

This note has been prepared by EPRS for the European Parliament’s Open Days in May 2017.

Organoids are artificially grown organs that mimic the properties of real organs, providing new possibilities for treating diseases, drug development, and personalised and regenerative medicine.

Organoids are small clusters of human cells, grown in a laboratory environment to form three-dimensional structures that mimic the functionalities of real organs such as the liver, heart, and lungs. Organoids are either generated from resident progenitors in adult organs; or derived from one or a few cells from a tissue, embryonic stem cells or induced pluripotent stem cells, which can self-organise in three-dimensional culture owing to their self-renewal and differentiation capacities. These cell clusters are often grown in specially fabricated micro-containers that help the cells to arrange themselves, much as they would in an organ inside the human body. They closely resemble in vivo human tissue and possess the genetic characteristics of the people from whom they are taken, and so respond to drugs as the corresponding organ of the person in question would. These organ-like structures, which can be stored in biobanks, are not just a powerful tool to promote better understanding of the fundamental processes governing organ development in the human body, but also promise direct benefits for patient treatment and drug development.

Potential impacts and developments

As one of the most accessible and physiologically relevant models for studying the dynamics of stem cells in a controlled environment, organoids are expected to advance our understanding of tissue renewal, stem cell/niche functions and tissue responses to drugs, mutation or damage, as well as unlocking the mysteries of several brain diseases and neurological disorders. The blossoming of a technology that allows scientists to grow matter resembling brains, as well as livers, kidneys, intestines, and many other body parts, is seen as an important avenue to reconstituting organ functions ex vivo. Other possibilities include providing a sound model for preclinical screenings, targeted and personalised therapies, regenerative medicine applications, drug discovery and environmental toxicology testing.

The progress in generating organoids has extended organoid applications from a basic research tool to a translational platform with a wide range of downstream functions and uses that animal testing cannot offer, and could even revolutionise the drug discovery process. For instance, mini-guts can serve as a personalised drug-testing tool for cystic fibrosis (CF), whilst researchers are beginning to use brain organoids as accurate models for the study of a wide range of diseases such as autism, schizophrenia, and epilepsy.

Furthermore, liver-based cell organoids could form a complement to current organ transplantation to restore liver function of patients with metabolic liver disease and to serve as a model for metastasis growth, and for testing tumour cell response to current and newly discovered drugs. Pancreas organoids derived from adult pancreas stem cells are one of the most promising technologies for cellular and regenerative therapy. These ‘intestinoids’ already permit novel drug testing for cystic fibrosis and bowel cancer. Recently, scientists set up the world’s first ‘living biobank‘ to store patients’ tumours, and used the tissue to identify the most promising drugs for each person’s disease, while other scientists are making progress in creating larger assemblies of nerve cells, moving towards creating brain-sized organoids. In the near future, organoids will begin to enter routine medical use, as a way to shed light on diseases caused during embryonic development, or potentially as transplants to replace human patients’ diseased or failing natural organs. Organoids are also used to study what goes wrong, such as in neurons derived directly from patients with Alzheimer’s disease.

Alongside the benefits organoids could provide in terms of helping researchers to understand how real organs develop, and what can go wrong with that process, the scaling-up of organoids into reproducible and user-friendly systems and commercial manufacturing entails safety and ethical risks, given that culture methods are still in their infancy. Personalised organoids may facilitate the deployment of personalised medical trials, which may in turn pose new risks, and affordability concerns.

Similar conflicts may arise when considering the type of tissue generated. The closer scientists come to making a human brain, the greater the ethical issues. The concepts of human integrity in this context could be placed under significant threat.

Anticipatory law making

Although many of these technologies are still relatively new and require further validation and characterisation, the fact that organoids derived today from living tissues cultivated from participants’ stem cells may be stored for a very long/virtually infinite period of time underlines the urgency to deal with these issues now. Privacy requirements; terms and conditions of inclusion of participants in research/clinical trial settings; storage and use of organoids; and dissemination of results including incidental findings, all require attention. Informed consent is a major issue regarding inclusion of participants and the collection of their stem cells from residual tissue. Organoid biobanking also requires the development of tailor-made informed consent procedures that address the challenges associated with the fact that organoids are actually living mini-organs that could be used for a wide range of purposes, as well as the lack of an EU-wide legal framework on biobanks.

The use of organoids may complement or even reduce animal testing and the involvement of humans in an experimental setting, which may in turn trigger the modification of the existing medicinal testing, clinical trial and chemicals’ authorisation framework.

Another central issue is the question about ownership and commodification of bodily material, as well as how true to life an in vitro model of human development needs to be in order to be both scientifically valuable and ethically acceptable. As interest in organoid technology grows, the commercial development of more standardised, validated organoid culture media will also be valuable in ensuring that the organoid system becomes accessible to a wide range of academic and clinical scientists, thereby helping to maximise its potential.

This post is part of a series based on the EPRS publication ‘Ten more technologies which could change our lives‘, which draws attention to ten specific technologies and promotes further reflection about other innovations, in a follow-up to the 2015 ground-breaking publication ‘Ten technologies which could change our lives – potential impacts and policy implications‘. The publications explore the promises and potential negative consequences of these new technologies, and the role that the European Parliament as co-legislator could, and should, play in shaping these developments. The publications feed into the work and priorities of the Science and Technology Options Assessment (STOA) Panel and parliamentary committees.

Tell us what other important technological developments you see that might have a significant impact on the way we live in the future, and that would require European policy-makers’ attention, by leaving a comment below or completing our feedback questionnaire.

In July 2015, the Commission proposed a new regulation on energy efficiency labelling as part of its summer energy package. The proposed regulation seeks to restore the A-G scale for energy labelling; create a mechanism for rescaling products that can accommodate further improvements in energy efficiency; establish a product database on energy efficiency; and introduce a safeguard procedure to improve national market surveillance. The rescaling of different types of household products would be done through delegated acts from the Commission. While the proposal is supported by consumer and environmental groups, industry groups are concerned that a major change in energy labelling could have a negative impact on both producers and consumers, acting as a disincentive to greater energy efficiency.

The Council adopted a general approach in November 2015. The Parliament approved a series of legislative amendments in July 2016. After several trilogue meetings, a provisional agreement was reached in March 2017. The agreed text was subsequently approved by the Parliament on 13 June and by the Council on 26 June 2017.

EU climate and energy policies have performed well: carbon emissions have fallen significantly while the economy has continued to grow. Europe is on track to meet or even exceed its 2020 climate and energy targets. Having been key actors in concluding the 2015 Paris Agreement on climate change, the EU and its Member States are now taking further steps to fulfil their pledges made ahead of the Paris conference.

EU climate policies: ambitions and achievements

The EU has pursued climate policies since the 1990s, starting with energy efficiency labelling and standards. These policies were strengthened after the adoption of the Kyoto Protocol, which commits developed countries to reducing their carbon emissions. In 2005, the EU introduced the Emissions Trading System (ETS), the world’s first and biggest carbon market. Furthermore, it set concrete targets for 2020: a 20 % reduction of carbon emissions compared to 1990 levels, a 20 % share of renewable energy sources and a 20 % improvement in energy efficiency. To achieve them, the EU adopted legislation in numerous areas, such as emissions trading, renewable energy sources, energy efficiency targets and energy labels and standards, and introduced the rule that at least 20 % of its budget would be dedicated to climate action, including research. Thanks to these measures, the EU has reduced its carbon emissions by 23 % since 1990, while its economy has grown by 46 %.

While the EU is fully on track to meeting or exceeding its targets for 2020, other regions have been less effective. Several countries have abandoned the Kyoto Protocol or weakened their climate policies. At the same time, emissions in many developing countries have grown rapidly, driven by strong economic growth.

The Paris Agreement: a global framework for climate action

After many years of difficult negotiations, in 2015 a new agreement on climate change was concluded at the 21st UN climate change conference (COP21) in Paris. The Paris Agreement was the first at which all countries, including developing ones, made commitments. The EU, together with the ‘high ambition coalition’ of 35 countries, played a leading role in raising the level of the goals set in the agreement. Ahead of COP21, the EU submitted its pledge, a 40 % reduction of EU carbon emissions by 2030, compared with 1990 levels.

Putting the Paris Agreement into action

The EU is currently in the process of a complete overhaul of its climate and energy policy to achieve its 40 % emissions reduction target under the Paris Agreement, as well as its 2030 targets of a 27 % share of renewables and an improvement in energy efficiency of at least 27 %. The Commission has made a number of legislative proposals to pave the way for the transition towards a low-carbon economy, on topics such as reforming the ETS, effort sharing, land use and forestry, energy efficiency, buildings and the electricity market. The Commission’s proposals are now being discussed and amended by the European Parliament and Member States.

The case for raising the level of ambition

The UN Environment Programme’s latest emissions gap report finds that the current pledges are not sufficient to limit the global temperature rise to the agreed 20C, let alone to 1.5oC. The Paris Agreement includes a mechanism for reviewing the pledges every five years, starting in 2018. The European Parliament has repeatedly called for greater ambition, such as a 40 % improvement in energy efficiency by 2030. In the context of the ETS reform, the European Parliament has urged more emission allowances to be removed from the market, the inclusion of the shipping and aviation sectors, and called for periodic reviews of the level of ambition in line with the five-yearly review cycle of the Paris Agreement.

This note has been prepared by EPRS for the European Parliament’s Open Days in May 2017.

The European Parliament has recently called upon the Commission to table a legislative proposal laying down a set of civil law rules on robotics and artificial intelligence. These should address such issues as liability for damages caused by a robot, as well as establish a European agency for robotics and artificial intelligence.

Growing numbers of robots

Shutterstock / Willyam Bradberry

Between 2010 and 2014, the average increase in sales of robots stood at 17 % per year, and in 2014 sales rose by 29 %. The main drivers of the growth are automotive parts suppliers as well as the electrical and electronics industries. In January 2015, the European Parliament’s Legal Affairs Committee established a working group on legal questions related to the development of robotics and artificial intelligence in the EU, with a focus on civil law aspects. The group held 10 meetings between May 2015 and September 2016, and heard advice from a number of stakeholders, scientists and lawyers. In June 2016, the EPRS Scientific Foresight Unit published an expert study on the Ethical Aspects of Cyber-Physical Systems (CPS). CPS are intelligent robotics systems, linked with the Internet of Things, or technical systems of networked computers, robots and artificial intelligence that interact with the physical world. Examples include automated cars and drones, as well as robots used in healthcare, as aids for disabled people and in agriculture. The study drew attention to possible risks from the development of robotics, including such aspects as employment, privacy protection, safety and civil liability.

Parliament’s resolution

On 16 February 2017 Parliament adopted a resolution formally requesting the Commission to bring forward a legislative proposal establishing civil law rules on robotics and artificial intelligence, governing in particular questions of liability and ethics of robotics.

Registering smart robots

The resolution proposes to introduce a system of registration for ‘smart robots’, that is, those which have autonomy through the use of sensors and/or interconnectivity with the environment, which have at least a minor physical support, which adapt their behaviour and actions to the environment and which cannot be defined as having ‘life’ in the biological sense. The system of registration of advanced robots would be managed by an EU agency for robotics and artificial intelligence. This agency would also provide technical, ethical and regulatory expertise on robotics.

Liability for damages caused by robots

As regards liability for damage caused by robots, the resolution suggests that liability could either be based on strict liability (no fault required) or on a risk-management approach (liability of a person who was able to minimise the risks). Liability should be proportionate to the actual level of instructions given to the robot and to its degree of autonomy. Rules on liability could be complemented by a compulsory insurance scheme for robot users, and a compensation fund to pay out in cases where no insurance policy covered the risk.

Codes of conduct

The resolution proposes, as an annex, two draft codes of conduct – a Code of Ethical Conduct for Robotics Engineers and a Code for Research Ethics Committees. The first code puts forward four ethical principles in robotics engineering: 1) beneficence (robots should act in the best interests of humans); 2) non-maleficence (robots should not harm humans); 3) autonomy (human interaction with robots should be voluntary); 4) justice (the benefits of robotics should be distributed fairly).

This note has been prepared by EPRS for the European Parliament’s Open Days in May 2017.

European roads are the safest in the world, and the introduction of the new harmonised European driving licence is helping to consolidate this trend. In addition to ensuring freedom of movement for the EU’s 300 million drivers – given that the new licences are recognised throughout Europe – they also reinforce their security and safety. The introduction of minimum requirements to obtain and keep a licence contributes to keeping unsafe drivers off the road. And thanks to the standardised credit-card style format, the risk of counterfeiting has been significantly reduced.

Standardisation of European driving licences

In January 2013, the new European driving licence was introduced, thanks to the adoption of the EU Driving Licence Directive (2006/126/EC) and its transposition by Member States in 2011. The 170 different formats of driving licences previously used are gradually being replaced with the harmonised licence. Given that a driving licence can in some cases also be used as an identification document, the new credit-card style licence includes a microchip equipped with anti-fraud technology. Communication between national authorities has improved through regular consultation within the RESPER network, where national authorities can exchange information and gain a better overview of individuals whose licences have been withdrawn, suspended or restricted. In turn, authorities can better detect driving licence falsification. Directive 2015/413 also facilitates the cross-border exchange of information on road safety-related traffic offences.

On the road to safer travel

Along with related measures, the standardisation of driving licences will positively affect road safety in Europe. Even though the number of deaths on European roads has drastically decreased – by 43 % between 2001 and 2010, and a further 19 % from 2010 onwards – there were still 25 500 road deaths in 2016 and 135 000 injuries. A 2011 European Commission transport white paper set the goal of zero victims of road accidents by 2050 and fatalities halved by 2020. The new driving licence rules enhance the safety of drivers, as they better protect vulnerable users. This is particularly the case for young motorcycle riders, whose access to motorbikes and powered two-wheelers will depend on their experience with less powerful machines, such as mopeds. Moreover, unless an individual’s driving licence was issued before 2013, both motorcyclists and car drivers will need to renew it every 10 or 15 years, depending on the Member State in which it was issued. Drivers of buses and lorries will hold licences valid for up to five years, and will need to undergo a medical examination to renew it.

EU action on road safety

The EU faces significant challenges in improving road safety, from ageing populations to the surge in the use of potentially distracting electronic devices on the road, but it also has opportunities through possibilities offered by new technologies such as self-driving systems. To monitor progress, the European Road Safety Observatory (ERSO) was set up to coordinate all EU activities in the fields of road accident and injury data collection. Within the EU, road safety is a shared competence, which means that the enforcement of traffic rules and education for road users are largely dealt with by Member States. EU intervention mostly focuses on the safety of road networks, training of professional drivers, the technical condition of vehicles, transport of dangerous goods, and harmonisation of vehicles in areas such as use of seat belts and speed limitation devices. In reaching the goal of zero road accidents by 2050, further action is still needed, though, through a combination of actions at local, national and EU level.

This note has been prepared by EPRS for the European Parliament’s Open Days in May 2017.